Pharmacovigilance: participation of patients and health professionals will improve the system

The Commission sought to limit patients' participation in adverse effects monitoring in its draft Regulation. This time it rejects the idea that the packaging of new drugs should bear words encouraging patients to report adverse events during the first five years that the product is on the market. Their argument is that adverse effects must always be notified, whatever the drug. This is indeed the case, but too few patients currently report adverse events; it is highly desirable that they participate in the pharmacovigilance of new drugs, which, by definition, are the least well known.
Amendment 81, article 1 point 40 must be upheld as formulated by the European Parliament.

The Commission considers that the need to take into account pharmacovigilance data collated outside the European Union, and those contained in the World Health Organisation database, is beyond the scope of the Directive. The Forum fails to understand how, with the increasing globalisation of the pharmaceuticals market, one can afford to ignore international data on adverse effects.
Recital 15 (amendment 172) of the Directive simply states this principle and must be upheld; otherwise, Europe will find itself on the margins of international scientific knowledge.

The Forum is also worried by the Commission's systematic attempts to deprive patients and health professionals of ready access to pharmacovigilance data. (See the paragraph below on transparency and access to documents.)

©La revue Prescrire, for the Medicines in Europe Forum 7 April 2003